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76 device results listed.

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i-GFBP-1+FFN three line Combo Rapid Test

1Test/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303308
Basic UDI-DI: B-06974566303308
Reference: FGF-5221
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

i-GFBP-1+FFN three line Combo Rapid Test

20Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303292
Basic UDI-DI: B-06974566303292
Reference: FGF-52220
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Hungary
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

TriClear CA/TV /GV Antigen Combo Rapid Test Kit

20T

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Shenzhen Reagent Technology Co., Ltd.
Manufacturer SRN: CN-MF-000047757
UDI-DI: 06974443201468
Basic UDI-DI: B-06974443201468
Reference: RNS92331
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Cyprus
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:08

Manufacturer products Authorised representative products Authorised representative actors View details

Detection Kit for Dengue virus/Zika virus/ Chikungunya virus (PCR-Fluorescence Probing)

MBD001-48

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870439
Basic UDI-DI: B-06974081870439
Reference: MBD001-48
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:51

Manufacturer products Authorised representative products Authorised representative actors View details

StrongStep® Candida albicans/Trichomonas vaginalis Antigen Combo Rapid Test

20 Tests/box

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Nanjing Liming Bio-products Co. Ltd
Manufacturer SRN: CN-MF-000041298
UDI-DI: 06973181850372
Basic UDI-DI: B-06973181850372
Reference: 500060
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 06.07.2026 16:52

Manufacturer products Authorised representative products Authorised representative actors View details

ToRCH IgM Combo Rapid Test

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598205358
Basic UDI-DI: B-06942598205358
Reference: ITOM-345
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 11:29

Manufacturer products Authorised representative products Authorised representative actors View details

Prueba Rápida de Combinación deNorovirus+Rotavirus+Adenovirus+ Astrovirus en Casete

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983126113
Basic UDI-DI: B-06936983126113
Reference: IMVD-645
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 11:19

Manufacturer products Authorised representative products Authorised representative actors View details

06970895474245

FLU A&B &COVID-19 & RSV & Adeno & MP Antigen Combo Test Cassette

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Jiangsu Mole Bioscience Co., LTD.
Manufacturer SRN: CN-MF-000001539
UDI-DI: 06970895474245
Basic UDI-DI: B-06970895474245
Reference: R225T020B0C0
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Slovakia
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 09:55

Manufacturer products Authorised representative products Authorised representative actors View details

Norovirus+Rotavirus+Adenovirus+Astrovirus Combo Rapid Test Cassette (Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06970277518741
Basic UDI-DI: B-06970277518741
Reference: IMVD-645
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.06.2026 00:39

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 and Influenza A+B Antigen Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06970277515726
Basic UDI-DI: B-06970277515726
Reference: ICIC-525
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Ireland
Authorised representative: VidaQuick Biotech S.L.
Last updated: 30.06.2026 00:39

Manufacturer products Authorised representative products Authorised representative actors View details

06955792731752

Mycoplasma genitalium/Mycoplasma hominis/Trichomonas vaginalis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731752
Basic UDI-DI: B-06955792731752
Reference: S3250E-24-P
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Portugal
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:31

Manufacturer products Authorised representative products Authorised representative actors View details

06955792731745

Mycoplasma genitalium/Mycoplasma hominis/Trichomonas vaginalis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731745
Basic UDI-DI: B-06955792731745
Reference: S3250E-48
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:31

Manufacturer products Authorised representative products Authorised representative actors View details

06955792714625

Mycoplasma genitalium/Mycoplasma hominis/Trichomonas vaginalis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792714625
Basic UDI-DI: B-06955792714625
Reference: S3250E-12-S
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

Norovirus+Rotavirus+Adenovirus+H.pylori+Clotridium difficile GDH+Toxin A+Toxin B Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598206881
Basic UDI-DI: B-06942598206881
Reference: IMGP-675
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Ireland
Authorised representative: VidaQuick Biotech S.L.
Last updated: 27.06.2026 01:19

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory 3 Panel

IVD generalNot specifiedOn the market

Manufacturer: GeneFirst Limited
Manufacturer SRN: GB-MF-000025181
UDI-DI: 05060670520074
Basic UDI-DI: B-05060670520074
Reference: RESP005
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Romania
Authorised representative: Advena Limited
Last updated: 20.06.2026 00:49

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory 1 Panel

IVD generalNot specifiedOn the market

Manufacturer: GeneFirst Limited
Manufacturer SRN: GB-MF-000025181
UDI-DI: 05060670520050
Basic UDI-DI: B-05060670520050
Reference: RESP003
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 20.06.2026 00:49

Manufacturer products Authorised representative products Authorised representative actors View details